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Sunday, May 19, 2013

Johnson & Johnson Ending Metal-on-Metal Hip Implant Sales (2)

Business Week Bloomberg

Johnson & Johnson (JNJ), the world’s biggest maker of health-care products, said it will stop selling metal-on-metal and ceramic-on-metal hip replacements as demand wanes for the devices and U.S. regulators seek new rules.

Metal liners in the Ultamet Metal-on-Metal Articulation and the Complete Ceramic-on-Metal Acetabular Hip System will no longer be available worldwide after Aug. 31, the New Brunswick, New Jersey-based company said in an e-mail. J&J’s DePuy Orthopaedics unit will stop selling related products through 2014 to simplify and streamline its offerings, the company said.

Metal-on-metal hip sales in the U.S. and Europe plunged from 20 percent of the market in 2007 to less than 2 percent last year as doctors questioned their safety and patients filed lawsuits citing flawed products. The global hip-implant market may be $5.7 billion in 2013, according to Lawrence Biegelsen, an analyst at Wells Fargo in New York. U.S. regulators earlier this year requested extensive study of all metal-on-metal hips.

“We won’t have any metal-on-metal or ceramic-on metal hips any longer,” said Mindy Tinsley, a spokeswoman for J&J’s DePuy unit, said in a telephone interview. “We’ve seen, for example, a 90 percent decline in metal-on-metal sales industrywide in the U.S. and Europe since 2007. There’s really not a viable market for these bearing combinations anymore.”

The decision to stop selling the hips isn’t related to safety or effectiveness, and it isn’t a recall, J&J said.

Existing Products

J&J will still market the Pinnacle Acetabular Cup System, one of the most widely used systems for hip replacement. It will also sell a wide range of liners and cups made with other materials, including ceramic and medical-grade plastics.

J&J rose less than 1 percent to $88.09 at the close in New York. The shares (JNJ) gained 39 percent in the past 12 months.

The decision to stop selling the products was unrelated to the 2010 recall of J&J’s ASR metal-on-metal hips, Tinsley said. The company is facing more than 10,000 lawsuits over the ASR products. J&J lost the first trial on March 8, when a Los Angeles jury ruled the ASR was defectively designed.
Ultamet was approved in 2000 through a less-extensive 510(k) process, which lets manufacturers compare their new offerings with similar products already on the market. The Food and Drug Administration in January said it wants hip replacement products that reached the market through the 510(k) process to undergo more rigorous study typically required for entirely new devices.
“DePuy made the decision to discontinue these products because of low clinician use of Ultamet and Complete, the availability of other options that meet the clinical needs of patients and proposed changes in FDA regulation of the entire class of metal-on-metal products, which includes Ultamet,” the company said in the statement.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net